Single Ascending Dose Study to Investigate BIA 12-3126 (QSC203658)
Research type
Research Study
Full title
A Double-blind, Randomised, Placebo-controlled, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetic and Pharmacodynamic Profile of BIA 12-3126 in Capsules in Healthy Male Subjects Under Fasted Conditions
IRAS ID
285219
Contact name
Ana Santos
Contact email
Sponsor organisation
BIAL – Portela & Cª., S.A
Eudract number
2020-002749-40
Duration of Study in the UK
0 years, 10 months, 15 days
Research summary
The Sponsor is developing the test medicine, BIA 12-3126, for the potential treatment of glaucoma. Glaucoma is a common eye condition where the optic nerve, which connects the eye to the brain, becomes damaged. It is usually caused by fluid building up in the front part of the eye, which increases pressure inside the eye. Glaucoma can lead to loss of vision if it is not diagnosed and treated early.
The study will try to identify the safety and tolerability of single ascending doses of the test medicine. It will also try to assess how quickly the body takes up and gets rid of the test medicine (pharmacokinetics). It may try to assess the effect of the body on the test medicine (pharmacodynamics).
The study will consist of 8 cohorts involving up to 64 healthy male volunteers. Each cohort will enrol 8 volunteers, who will be randomly assigned to receive the test medicine or matching placebo (total six volunteers will receive active and two will receive placebo). Sentinel dosing will be used for each cohort, meaning two volunteers will be dosed 48 hours before the rest of the group, so that their safety data can be reviewed before the rest are dosed. One will receive active test medicine and the other will receive the placebo. Volunteers will enter the clinical unit on Day -2 and will remain resident until Day 4. A follow-up visit will take place on between Day 9 and Day 13 or approximately three days after early withdrawal. There will be a period of 14 days between each cohort to allow for data review to determine the dose for the next cohort.
REC name
Wales REC 2
REC reference
20/WA/0218
Date of REC Opinion
21 Aug 2020
REC opinion
Further Information Favourable Opinion